Patient-Reported Data Tracking for Cancer

Overseen By Erin Laurie-Zehr, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: No email, No smartphone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an electronic survey tool designed to predict and prevent delays in cancer treatment. Patients with newly diagnosed breast or colorectal cancer will complete weekly online questionnaires to monitor their treatment progress and identify potential roadblocks. The goal is to detect and address any factors that might delay treatment, potentially improving patient outcomes. This trial suits those recently diagnosed with breast or colorectal cancer who plan to receive treatment at the University of North Carolina. As an unphased trial, it allows patients to contribute to innovative research aimed at enhancing cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ePRO tool is safe for tracking treatment delays in cancer patients?

Studies have shown that electronic patient-reported outcome (ePRO) systems are generally safe and easy to use. Research indicates that these digital tools help manage symptoms and improve communication between patients and healthcare providers. No reports of serious side effects exist because the ePRO functions as an electronic survey. It enables patients to regularly share their health status from home, making it a low-risk tool compared to traditional medical treatments. Overall, using ePRO systems has not revealed any significant safety concerns, making it a safe option for patients in trials like this one. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about patient-reported data tracking for cancer because it provides real-time insights directly from patients about their symptoms and quality of life. Unlike traditional methods that rely on intermittent clinical assessments, electronic patient-reported outcome (ePRO) questionnaires allow for continuous, weekly updates. This approach has the potential to enhance personalized care and prompt timely interventions by capturing changes in a patient's condition more quickly. By directly involving patients in their treatment journey, this method could lead to more responsive and tailored cancer care.

What evidence suggests that this ePRO tool is effective for tracking cancer treatment delays?

Research shows that electronic patient-reported outcomes (ePROs) can significantly aid cancer treatment. In this trial, participants will complete weekly ePRO questionnaires. For instance, one study found that ePROs help identify potential treatment delays early. Early detection allows doctors to intervene sooner, improving treatment management. Another study found that patient-reported outcomes can enhance both the lifespan and quality of life for cancer patients. Regular check-ins with patients enable healthcare teams to address issues more quickly, potentially leading to more effective cancer care. ^{1 6 7 8 9}

Who Is on the Research Team?

Katie Reeder-Hayes

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a recent diagnosis of breast or colorectal cancer who plan to receive treatment at the University of North Carolina. They must be able to get and respond to surveys electronically and give consent. Those without email or smartphone access, unable to consent, or not fluent in English cannot join.

Inclusion Criteria

I am over 18 years old.

I have not started any cancer treatment yet.

I was diagnosed with breast or colorectal cancer in the last 6 weeks.

Exclusion Criteria

I am unable or unwilling to receive and complete surveys electronically.

Patient unwilling or unable to provide verbal or signed consent to participate

Patients who do not have email access or a smartphone are able to receive Short Message/Messaging Service (SMS) text messages.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants complete weekly electronic patient-reported outcome (ePRO) questionnaires to identify treatment delays

8 weeks

Weekly electronic surveys

Follow-up

Participants are monitored for treatment initiation and delays using ePRO and EHR tools

8 weeks

Analysis and Reporting

Data from ePRO and EHR are analyzed to assess treatment delays and racial disparities

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Weekly Survey

Trial Overview The study tests an electronic tool where patients report issues that might delay their cancer treatment. It aims to identify if there's a link between race, social factors, and treatment delays using patient feedback and health records.

How Is the Trial Designed?

Group I: electronic patient-reported outcome (ePRO) questionnaires. Experimental Treatment 1 Intervention

Subjects with colon or breast carcinoma will respond to weekly electronic patient-reported outcome (ePRO) questionnaires.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Published Research Related to This Trial

The study involved 127 cancer patients undergoing chemotherapy or radiation therapy, and it confirmed that most adverse event (AE) terms in the PRO-CTCAE library were easily understood by patients, regardless of their education level.

Minor modifications were made to 17 AE terms to enhance clarity and comprehension, ultimately supporting the content validity of the PRO-CTCAE for accurately capturing patient-reported outcomes during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Hay, JL., Atkinson, TM., Reeve, BB., et al.[2022]

In a study of 484 colorectal cancer patients, 61% opted to receive individual feedback reports on their patient-reported outcomes, which 92% found useful.

Patients who received feedback had a higher response rate to follow-up questionnaires, indicating that such reports may enhance patient engagement and retention in studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an individual feedback report on patient-reported outcomes in the Prospective Dutch ColoRectal Cancer cohort. Vissers, PAJ., Vink, GR., Koelink, MR., et al.[2022]

Patient-reported outcomes (PROs) are increasingly important in randomized clinical trials for cancer, as they provide insights into how patients experience treatments, which cannot be captured by clinician reports alone.

The commentary highlights nine clinical trials where PROs significantly contributed to understanding treatment effects, demonstrating their value in guiding clinical practice, informing patients, and aiding health policy decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Listening to the Patient Voice Adds Value to Cancer Clinical Trials. Brundage, MD., Crossnohere, NL., O'Donnell, J., et al.[2023]

A study involving 60 patients and 50 providers revealed that bar charts and line graphs are preferred over pictographs for displaying patient-reported outcomes (PROs) related to health-related quality of life (HRQOL) after prostate cancer treatment.

Pilot testing of personalized PRO dashboards with 12 patients showed improved compliance with quality indicators for prostate cancer care, indicating that these dashboards can effectively integrate patient-generated data into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and feasibility of integrating personalized PRO dashboards into prostate cancer care. Hartzler, AL., Izard, JP., Dalkin, BL., et al.[2018]

Using patients' own smartphones to monitor quality of life (QoL) indicators in cancer clinical trials could significantly reduce the resources and personnel needed for continuous monitoring.

A pilot study demonstrated that the Human Dynamics Reporting Service (HDRS) app can effectively track physical, psychological, social, and environmental aspects of patients' lives, linking them to standardized QoL measures like the EORTC QLQ-C30.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone Sensors for Monitoring Cancer-Related Quality of Life: App Design, EORTC QLQ-C30 Mapping and Feasibility Study in Healthy Subjects. Asensio-Cuesta, S., Sánchez-García, Á., Conejero, JA., et al.[2023]

A study involving 25 women with breast cancer revealed that using a real-time tracking tool improved the consistency of symptom tracking compared to traditional methods, which were often fragmented.

Participants reported that the tracking tool helped them identify patterns in their symptoms, provided psychosocial comfort, and enhanced their communication with healthcare providers, suggesting it could lead to better symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probing the benefits of real-time tracking during cancer care. Patel, RA., Klasnja, P., Hartzler, A., et al.[2022]

A study involving 262 cancer patients in Japan found that 60% consented to participate in a touch screen tablet survey, with a completion rate of 58%, indicating a generally positive response to this method of data collection.

The majority of patients (92%) found the touch screen survey easy to use, and 95% felt comfortable answering the questions, although older patients were more likely to require assistance, suggesting that this method may need adjustments for certain demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a Touch Screen Tablet Psychosocial Survey Administered to Radiation Therapy Patients in Japan. Suzuki, E., Mackenzie, L., Sanson-Fisher, R., et al.[2018]

A feasibility study involving 73 breast cancer patients demonstrated that using the LINE app for daily patient-reported outcomes (PROs) led to a high response rate of 95.5%, with an average of 224.9 reports per patient over a median observation period of 435 days.

The system's design, utilizing a popular social media application rather than a specialized tool, contributed to its acceptance across all age groups, including older patients, indicating that familiar technology can enhance patient engagement in reporting symptoms during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study on collecting patient-reported outcomes from breast cancer patients using the LINE-ePRO system. Hayashida, T., Nagayama, A., Seki, T., et al.[2022]

A survey of 727 stakeholders in cancer clinical research revealed that 93% believe patient-reported outcomes (PROs) for adverse events would enhance understanding of patient experiences during treatment.

The majority of respondents (88%) felt that using the PRO-CTCAE would improve the quality and efficiency of symptom data collection, indicating strong support for its implementation in clinical trials to inform treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Bruner, DW., Hanisch, LJ., Reeve, BB., et al.[2022]

Patient-reported data from 4,174 patients with lung or colorectal cancer indicated that a high percentage of patients met quality indicators for symptom screening (74% to 93%) and treatment (73% to 99%), suggesting that patients felt their symptoms were being adequately addressed.

In contrast, medical record data showed much lower percentages of patients meeting the same quality indicators (4% to 23%), highlighting the potential for patient-reported data to provide a more accurate and patient-centered view of the quality of supportive oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the quality of supportive oncology using patient-reported data. Dy, SM., Walling, AM., Mack, JW., et al.[2022]

The review of six studies found that while patient-reported outcome measures (PROMs) are used in cancer clinics, their impact on improving patient outcomes like quality of life and satisfaction is limited, indicating a need for better implementation strategies.

Future interventions should focus on training healthcare professionals to effectively use PROM data, enhancing patient self-efficacy, and ensuring that PROMs are specific and interpretable, while future trials should adopt cluster-randomized designs to better control for contamination and link PROM use to patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient outcomes through the routine use of patient-reported data in cancer clinics: future directions. Luckett, T., Butow, PN., King, MT.[2022]

Patient-reported outcome measure (PROM) feedback interventions in oncology showed a positive impact on health-related quality of life (HRQL) and patient-healthcare provider communication, with a moderate effect size based on a meta-analysis of 29 studies involving 7071 cancer patients.

The intervention also demonstrated a significant improvement in 1-year overall survival rates, suggesting that providing feedback can enhance care processes and outcomes for cancer patients, although the findings are limited by a high risk of bias in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. Lu, SC., Porter, I., Valderas, JM., et al.[2023]

In a study involving 37 men with metastatic prostate cancer, patient-reported symptoms using the QLQ-C30 questionnaire identified 55 symptoms that physicians did not report, highlighting a significant gap in symptom detection by clinicians.

Physician reporting of chemotherapy side effects showed low sensitivity (47%) and specificity (68%) compared to patient reports, indicating that relying solely on clinician assessments may overlook important adverse events experienced by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. Fromme, EK., Eilers, KM., Mori, M., et al.[2022]

The study aims to evaluate a smartphone application designed for real-time reporting of adverse events in cancer treatments, which could enhance early detection and management of side effects, ultimately improving patient safety and treatment outcomes.

The trial will involve 66 patients over six months, assessing the feasibility of the app and comparing the quality of life and therapy doses between those using the app and those receiving standard care, highlighting the importance of patient-reported symptoms in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. Kestler, AMR., Kühlwein, SD., Kraus, JM., et al.[2021]

Direct patient reporting of adverse events in cancer treatment through electronic interfaces may improve the accuracy and completeness of symptom reporting, addressing the issue of underreporting by clinical staff.

The National Cancer Institute is developing and testing a new system called the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, which aims to enhance the collection of adverse symptom information from patients in clinical research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic toxicity monitoring and patient-reported outcomes. Basch, EM., Reeve, BB., Mitchell, SA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11325109/

Examining the Effectiveness of Electronic Patient-Reported ... The aim of this study was to compare the isolated effect of administering ePROs to patients with cancer versus a control condition.

2. ascopubs.org ascopubs.org/doi/abs/10.1200/OP.2025.21.10_suppl.397

Development of a brief electronic patient reported outcome ... We tested a brief ePRO tool, CareTracker, to proactively identify impending treatment delays for newly diagnosed breast and colorectal cancer ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11700045/

Electronic patient-reported outcomes as digital ... This review delineates the advantages and challenges of ePROs according to their history and proposes the prospects of ePRO.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822297

Patient-Reported Outcome Measures in Cancer Care The findings of this study suggest that the integration of PROMs into cancer care may improve overall survival and quality of life.

5. becarispublishing.com becarispublishing.com/doi/10.57264/cer-2023-0157

Implementation of electronic patient-reported outcomes for ... Real-world impact of patient-reported outcome measurement on overall survival, healthcare use and treatment discontinuation in cancer patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11135117/

The advantages, disadvantages, threats, and opportunities of ... Electronic patient-reported outcome (ePRO) systems have great potential to solve various problems in cancer care. These systems can facilitate ...

7. ascopubs.org ascopubs.org/doi/10.1200/OP.24.00050

Electronic Patient-Reported Outcome-Driven Symptom ... We developed and implemented an electronic patient-reported outcome (ePRO)–driven symptom management tool led by oncology pharmacists in a majority-minority ...

8. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2025.1560533/pdf

Electronic patient-reported outcome systems and ... Conclusion: Our systematic review of electronic patient-reported outcome. (ePRO) systems in cancer care focused on the capabilities of these ...

9. jmir.org jmir.org/2024/1/e49089/

Examining the Effectiveness of Electronic Patient-Reported ... The aim of this study was to compare the isolated effect of administering ePROs to patients with cancer versus a control condition.